Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04664270
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2020-12-05
Brief Title:
Developing and Implementing E-psychotherapy Program for Mental Health Challenges in Oncology and Palliative Care
Sponsor:
Dr Nazanin Alavi
Organization:
Queens University
Study Overview
Official Title:
Developing and Implementing an Online Psychotherapy Program to Address Mental Health Challenges in Oncology and Palliative Care
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The demand for mental health problems particularly depression and anxiety is three times greater in Oncology and Palliative Care Centres than in the general population There are unique factors in this population that make them more susceptible to mental health challenges The disease itself the adjustment to a chronicfatal diagnosis and the treatment options can all perpetuate the development of mental illness Despite the well-established association there have been barriers to access suitable treatment for these patients
Online Psychotherapy is an effective treatment option that may address many of these barriers This modality has been proven effective in addressing depression and anxiety in other populations To date there has been no psychotherapy module developed specifically for oncology and palliative care patients to our knowledge The aim is to establish the first academic e-psychotherapy treatment option to address mood and anxiety disorders in oncology and palliative care patients The investigators will use the Online Psychotherapy Tool OPTT a secure cloud-based platform for online delivery of e-CBT developed by the PI
The proposed study aims to establish the feasibility and effectiveness of delivering online psychotherapy to oncology and palliative care patients who have a comorbid depressive or anxiety disorder The patients will be enrolled in an 8-week program with a combination of cognitive behavioural therapy CBT and Mindfulness techniques delivered via a series of modules They will receive individualized feedback from a trained therapist weekly It is hypothesized that delivering this psychotherapeutic intervention in this manner will have great adherence The aim is to prove that it will improve the quality of life and decrease symptoms of depression and anxiety in this underserved patient population
Online Psychotherapy is an effective treatment option that may address many of these barriers This modality has been proven effective in addressing depression and anxiety in other populations To date there has been no psychotherapy module developed specifically for oncology and palliative care patients to our knowledge The aim is to establish the first academic e-psychotherapy treatment option to address mood and anxiety disorders in oncology and palliative care patients The investigators will use the Online Psychotherapy Tool OPTT a secure cloud-based platform for online delivery of e-CBT developed by the PI
The proposed study aims to establish the feasibility and effectiveness of delivering online psychotherapy to oncology and palliative care patients who have a comorbid depressive or anxiety disorder The patients will be enrolled in an 8-week program with a combination of cognitive behavioural therapy CBT and Mindfulness techniques delivered via a series of modules They will receive individualized feedback from a trained therapist weekly It is hypothesized that delivering this psychotherapeutic intervention in this manner will have great adherence The aim is to prove that it will improve the quality of life and decrease symptoms of depression and anxiety in this underserved patient population
Detailed Description:
Sixty patients n60 diagnosed with depressive or anxiety disorder due to another medical condition in the context of cancer or palliative care will be recruited to the study through referrals from health care professionals at Kingston Health Sciences Centre KHSC including cancer centre Providence Care Hospital PCH family physicians and other health care providers or self-referrals After consenting to take part in the study a complete assessment will be done by one of the psychiatrists on the team to confirm the diagnosis Inclusion criteria include 18-55 years of age at the start of the study diagnosed with depression or anxiety secondary to a general medical condition in the context of cancer or palliative condition according to the Diagnostic and Statistical Manual of Mental Disorders 5th Edition DSM-5 by one of the psychiatrists on the team competence to consent and participate ability to speak and read English and consistent and reliable access to the internet Exclusion criteria include acute hypomanicmanic episodes acute psychosis severe alcohol or substance use disorder and active suicidal or homicidal ideation or if they have received CBT in the past year or are currently receiving CBT Participants will then be randomly assigned to two groups e-psychotherapy group online CBT mindfulness problem solving or treatment as usual TAU ie medication psychiatric consultation and referrals to in-person activitiesgroups arms of the study n30 for each group The TAU arm acts as the control group of the study
Upon completion of the initial assessment if eligible for the study participants will randomly be assigned to one of the two arms of the study Patients in the e-CBT group will receive an 8-week online program including CBT in combination with mindfulness and problem-based therapy in addition to treatment as usual The content of this program will be customized to reflect challenges cancer and palliative patients face through the course of their treatment and developed into interactive and engaging therapy modules All online sessions and interactions will occur through a secure online platform ie OPTT Through the platform the pre-designed therapy modules are assigned to the patients accessible to them at any time throughout the week Each module consists of approximately 30 slides which take an average of 45-50 minutes to complete Each weekly module highlights a different topic and includes general information an overview of skills and homework that is to be completed within that week This homework can be directly submitted through the platform to the clinician who will then provide personalized feed-back to the patient The average time spent per week by a clinician with a particular patient is about 15 minutes The control group will receive treatment as usual in the first 8 weeks if still significantly symptomatic less than 50 response to treatment from baseline they will then be offered the 8-week e-psychotherapy program
Upon completion of the initial assessment if eligible for the study participants will randomly be assigned to one of the two arms of the study Patients in the e-CBT group will receive an 8-week online program including CBT in combination with mindfulness and problem-based therapy in addition to treatment as usual The content of this program will be customized to reflect challenges cancer and palliative patients face through the course of their treatment and developed into interactive and engaging therapy modules All online sessions and interactions will occur through a secure online platform ie OPTT Through the platform the pre-designed therapy modules are assigned to the patients accessible to them at any time throughout the week Each module consists of approximately 30 slides which take an average of 45-50 minutes to complete Each weekly module highlights a different topic and includes general information an overview of skills and homework that is to be completed within that week This homework can be directly submitted through the platform to the clinician who will then provide personalized feed-back to the patient The average time spent per week by a clinician with a particular patient is about 15 minutes The control group will receive treatment as usual in the first 8 weeks if still significantly symptomatic less than 50 response to treatment from baseline they will then be offered the 8-week e-psychotherapy program
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None